Using nalbuphine for pain management in ARDS patients after surgery

Analgesic Effect and Safety Analysis of Nalbuphine in ARDS Patients After Surgery

This study is testing if nalbuphine can help manage pain and anxiety better than another pain medication for patients with Acute Respiratory Distress Syndrome after surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06037330 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of nalbuphine, a semi-synthetic opioid, for managing pain and sedation in patients with Acute Respiratory Distress Syndrome (ARDS) following surgery. It is a single-center, randomized, single-blind, prospective trial comparing nalbuphine to sufentanil in critically ill patients. The study aims to assess how nalbuphine can improve patient comfort while minimizing adverse effects commonly associated with other opioids. The research focuses on patients who have undergone surgery within the last week and are experiencing moderate pain and anxiety in the ICU setting.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have undergone surgery within the past week and meet the diagnostic criteria for ARDS.

Not a fit: Patients with severe liver dysfunction, high APACHE II scores, or those with specific contraindications such as severe craniocerebral injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective analgesic option for ARDS patients in critical care.

How similar studies have performed: Previous studies have shown promising results for nalbuphine in ICU settings, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Had undergone surgical treatment within 7 days before enrollment;
* Meet the diagnostic criteria for ARDS proposed at the 2011 Berlin ARDS Definition Conference;
* Age ≥18 years old, gender unlimited;
* Patients admitted to ICU with CPOT score ≥3;
* Stay in ICU ≥48h;
* Sign the informed consent form.

Exclusion Criteria:

* APACHE II score ≥23 points;
* Patients with esophageal reflux disease and severe gastrointestinal injury have AGI score ≥3;
* Long-term use of narcotic analgesics, hypnotics and psychotropic drugs;
* Alcohol withdrawal symptoms;
* Severe liver dysfunction (Child-Pugh grade C);
* Patients with bronchial asthma and myasthenia gravis;
* Patients with severe craniocerebral injury, brain tumor, and increased intracranial pressure are prone to respiratory depression;
* Patients undergoing cardiac surgery under cardiopulmonary bypass;
* Patients who have been enrolled in other clinical trials;
* Study patients with drug allergy or other contraindications;
* Pregnant or lactating women;
* The patient himself or his legally authorized representative is unwilling to sign the informed consent;

Where this trial is running

Jinan, Shandong

• Department of Intensive Care Medicine — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Quanzhen Wang, doctor

Conditions: Acute Respiratory Distress Syndrome